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Sunday, April 9, 2017

GlaxoSmithKline Recalling Ventolin Inhalers for Possible Package Leakage














GlaxoSmithKline (GSK) issued a voluntary Class II recall on April 4, 2017 for three lots of Ventolin® HFA 200D Inhalers from U.S. hospitals, pharmacies, retailers and wholesalers as a precautionary measure. It is not a consumer recall.
The lot numbers are:

·         6ZP0003
·         6ZP9944
·         6ZP9848

A GSK spokesman spoke with AAFA and said the recall is due to some complaints about the overwrap, or pouches containing the inhalers, becoming inflated by leaking from the product. The leaking may cause the inhaler to deliver fewer doses than shown on the dose counter. 
Patients are not being told to return the inhalers. If you have a question, call the company’s response center: 1-888-825-5249.

A Class II recall is one where "use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote," according to the U.S. Food and Drug Administration.

The company released a statement that said, “Though the overall benefit-risk assessment for Ventolin® HFA 200D Inhaler when used at prescribed doses remains favourable, in this situation, there is possible risk to patients of experiencing diminished bronchodilation in the setting of acute bronchospasm if reliant on a rescue inhaler that could potentially not deliver the stated number of actuations. GSK is committed to supplying high quality product and patient satisfaction, and we sincerely regret any inconvenience this recall may cause."


If you need to fill a prescription for Ventolin HFA 200D, the voluntary recall should not affect pharmacy supplies. 

Source: AAFA
www.gmpviolations.com GMP News, GMP guidelines, GMP Violations, GMP warnings, GMP Trends. A Public Health Global News Portal. (This story has not been edited by GMP Violations staff and is auto-generated from a syndicated feed/ experts experiences sharing.) Disclaimer: The Logos/Images & content posted here are belongs to respective to Authority / owners of firm. The Article posted under public health importance news. Please ensure the guideline as per Regulatory agencies.
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